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A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Verified by: Eli Lilly and Company, October 2010

First Received: September 12, 2005 | Last Updated: August 18, 2011

Phase: Phase 4 | Start Date: September 2004

Overall Status: Completed | Estimated Enrollment: 502

Brief Summary

Official Title: “A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning”

This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.

Detailed Clinical Trial Description

The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).

Interventions Used in this Clinical Trial

Drug: Atomoxetine Hydrochloride

Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally

Drug: Placebo

Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Arms, Groups and Cohorts in this Clinical Trial

Experimental: Atomoxetine

Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally

Placebo Comparator: Placebo

Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)

Time Frame: Baseline 12 weeks, 24 weeksSafety Issue?: No

Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)

Time Frame: Baseline, 12 weeks, 24 weeksSafety Issue?: No

Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

Time Frame: Baseline, 1 weekSafety Issue?: No

Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

Time Frame: Baseline, 2 weeksSafety Issue?: No

Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo

Time Frame: Baseline, after 2-week titration period beginning at Week 24Safety Issue?: No

Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and 3.

Adult Men and Women age 18 years or older at time informed consent is obtained.

Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.

Must have one or more children 6-17 years of age living the home as the primary residence.

Exclusion Criteria

Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder.

Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder.

Taking psychotropic medications on a regular basis.

Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial.

Additional Information on this Clinical Trial

Link to the current ClinicalTrials.gov record. – https://clinicaltrials.gov/show/NCT00190775

Study ID Number: 9043

ClinicalTrials.gov Identifier: NCT00190775

Health Authority: United States: Food and Drug Administration

Source

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